NECESSITY,
FUNCTION, AND CONFORMITY: KRS Chapter 333 authorizes the Cabinet for Human
Resources to periodically inspect medical laboratories in Kentucky and to
withhold the issuance of a license to the medical laboratory until the cabinet
determines that the laboratory is adequately staffed and equipped to operate in
conformity with the requirements of KRS Chapter 333 and the administrative
regulations promulgated thereunder. KRS Chapter 333 directs the Secretary for
Human Resources to adopt rules and regulations to effectuate the purposes of
KRS Chapter 333 including the licensure of medical laboratories, standards of
performance in the examination of specimens, and the operation by the cabinet
of a medical laboratory evaluation program. This administrative regulation
describes the proficiency test program which shall be employed by the cabinet
to evaluate the work of medical laboratories.

Section 1.
Definitions. (1) "Reference laboratory" means a laboratory designated
by the cabinet to authenticate the identification, content, or titer of samples
and other materials used in proficiency testing.

(2)
"Referee laboratory" means a laboratory designated by the cabinet to
examine specimens or other materials for proficiency testing using the time
schedule allowed for licensed laboratories and under conditions similar to
those under which licensed laboratories examine materials.

Section 2.
Proficiency Testing; Procedures, Samples, Test Conditions. Applicants and
licensees shall be subject to a proficiency testing program approved by the
cabinet, to aid in assessing the competency of laboratory staff and the
adequacy and quality of facilities, equipment, reagents, working conditions,
and procedures. Testing may be carried out during on-site inspections by the
cabinet or by submittal to laboratories of samples for examination. In
conducting testing, the following rules shall apply:

(1) The
laboratory shall be tested only in those procedures or specialties of
procedures for which a license application, original or renewal, has been filed
with the cabinet, or for which the cabinet has issued a license.

(3) Samples to
be tested may be provided prior to, during, or subsequent to inspections.

(4) Time allowed
for testing of samples shall be the time required under conditions of normal
laboratory operations, as determined by the cabinet.

(5) Laboratory
personnel shall enter the date and time of receipt of samples, results of
tests, and other information required by the cabinet, on forms provided or
required by the cabinet.

Section 3.
Proficiency Testing; Reference Laboratories and Referee Laboratories. Samples
identical to those submitted to the applicant or licensee laboratory shall be
submitted to reference or referee laboratories designated by the cabinet.

Section 4.
Proficiency Testing; Reporting of Test Scores. (1) If laboratory reports
reflect a lack of proficiency, the cabinet may recommend corrective measures,
consultation, or training in an appropriate laboratory and may, upon written
request of the laboratory director, furnish the laboratory with additional
samples after corrective measures have been taken.